Pterygium Clinical Trial
Official title:
Topical Bevacizumab 0.05% Eye Drops for Preventing Recurrent Pterygium, A Randomized, Double-masked, Controlled Trial
The purpose of this study is to determine whether bevacizumab eye drop is effective in the treatment of recurrent pterygium.
A pterygium is a degenerative and proliferative fibrovascular disorder of the ocular
surface. Patients may be asymptomatic, irritation, decreased vision, diplopia or limit
ocular movement. The mainstay treatment is surgical removal of the head, neck and body of
the pterygium. However, if there is no adjunctive treatment, the recurrence is unacceptably
high which is 63% in general. Various adjunctive measures are applied to prevent recurrence
including use of mitomycin C, beta-irradiation and surgical methods such as conjunctival and
amniotic membrane graft. However, each method has its advantages and disadvantages.
The histologic finding of recurrent pterygium often has aggressive fibrovascular growth.
Vascular endothelial growth factor(VEGF)has been detected in increased amounts in pterygium
tissue, compared with normal conjunctiva and it is also correlated with post-operative
recurrence. Bevacizumab, an Anti-VEGF, binds to VEGF and prevents the interaction of VEGF to
its receptors on the surface of vascular endothelial cells. Administration of bevacizumab
leads to inhibition of endothelial cell proliferation and new blood vessel formation. Even
though there are reported the efficacy of topical bevacizumab in inhibiting the impending
recurrent pterygium, there is no study for preventing recurrence after primary pterygium
removal.
We conduct a prospective, randomized, double-masked, controlled trial to evaluate the
efficacy of topical bevacizumab 0.05% eye drops for preventing recurrence in primary
pterygium.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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